Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/78—Means for handling the parts to be joined, e.g. for making containers or hollow articles, e.g. means for handling sheets, plates, web-like materials, tubular articles, hollow articles or elements to be joined therewith; Means for discharging the joined articles from the joining apparatus
  • B29C65/7802—Positioning the parts to be joined, e.g. aligning, indexing or centring
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
  • A61M39/146—Tube connectors; Tube couplings for connecting tubes having sealed ends by cutting and welding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
  • A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
  • B29C65/20—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools with direct contact, e.g. using "mirror"
  • B29C65/2046—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools with direct contact, e.g. using "mirror" using a welding mirror which also cuts the parts to be joined, e.g. for sterile welding
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/74—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/78—Means for handling the parts to be joined, e.g. for making containers or hollow articles, e.g. means for handling sheets, plates, web-like materials, tubular articles, hollow articles or elements to be joined therewith; Means for discharging the joined articles from the joining apparatus
  • B29C65/7841—Holding or clamping means for handling purposes
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/001—Joining in special atmospheres
  • B29C66/0012—Joining in special atmospheres characterised by the type of environment
  • B29C66/0018—Joining in special atmospheres characterised by the type of environment being sterile
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
  • B29C66/114—Single butt joints
  • B29C66/1142—Single butt to butt joints
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
  • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
  • B29C66/52—Joining tubular articles, bars or profiled elements
  • B29C66/522—Joining tubular articles
  • B29C66/5221—Joining tubular articles for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
  • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
  • B29C66/739—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
  • B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
  • B29C66/73921—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/80—General aspects of machine operations or constructions and parts thereof
  • B29C66/84—Specific machine types or machines suitable for specific applications
  • B29C66/841—Machines or tools adaptable for making articles of different dimensions or shapes or for making joints of different dimensions
  • B29C66/8414—Machines or tools adaptable for making articles of different dimensions or shapes or for making joints of different dimensions of different diameter
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/80—General aspects of machine operations or constructions and parts thereof
  • B29C66/84—Specific machine types or machines suitable for specific applications
  • B29C66/857—Medical tube welding machines
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/10—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using hot gases (e.g. combustion gases) or flames coming in contact with at least one of the parts to be joined
  • B29C65/103—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using hot gases (e.g. combustion gases) or flames coming in contact with at least one of the parts to be joined direct heating both surfaces to be joined
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
  • B29C65/1403—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the type of electromagnetic or particle radiation
  • B29C65/1412—Infrared [IR] radiation
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
  • B29C65/16—Laser beams
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
  • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
  • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
  • B29K2027/06—PVC, i.e. polyvinylchloride
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2023/00—Tubular articles
  • B29L2023/005—Hoses, i.e. flexible
  • B29L2023/007—Medical tubes other than catheters
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/753—Medical equipment; Accessories therefor

Definitions

• the present invention relates to sterile connection of thermoplastic tubing, and more particularly to an apparatus for sterile connection by welding.
• the invention also relates to a method of sterile connection of thermoplastic tubing by welding.
• the biotechnology industry uses different manufacturing systems for creating aseptic and sterile connections between process containers and equipment, such as plastic bags and pumps.
• a known manufacturing system uses controlled environments such as clean rooms or cabinets to ensure aseptic connections during manufacture. When necessary connections are made in such a controlled environment that breaches sterile tubing and piping, the environment does not contaminate the fluid flow passage. However, maintaining a clean room is time consuming, difficult and costly to validate.
• separation or reaction systems such as chromatography systems, filter systems or bioreactor systems have today at least partly been provided as disposable systems. This eliminates the need for cleaning and cleaning validation before processing, in between processes and cycles or after processing before re-use as required for conventional re-usable equipment. With disposable systems cross-contamination is avoided.
• Bioburden control of single-use equipment during manufacturing of the equipment itself is required to eliminate cleaning needs before bringing single-use equipment into product contact. This is usually achieved by manufacturing of single-use equipment in controlled environment (clean room), often followed by sterilisation processes (gamma irradiation).
• the demands of the level of bioburden control can differ for different applications.
• bioburden control to a certain degree of the equipment is not only required for some applications, but also considered as the preferable for most of the applications using disposable equipment.
• the production of this equipment in controlled environments is required to guarantee a low initial level of contaminants prior to the bioburden control procedure.
• Sterility and asepsis are terms used to define the state of a system, a piece of equipment or a fluid conduit as being in control of bioburden levels to different degrees.
• Many manufacturing systems use disposable plastic bags connected to flexible thermoplastic tubes, which requires special connections to assure that the bags and tubes remain clean and sterile.
• Known are also pre-sterile bags and tube sets which can be supplied with the appropriate special disposable aseptic connection system fittings already in place. These connections are simple, repeatable and validatable but they normally have to be applied during manufacture of the sets and are not amenable to the setting up of tailor-made systems directly in the bioprocess facility.
• One aspect of the invention is to provide a welding apparatus that enables aseptic welding of thermoplastic tubing having a range of different diameters. This is achieved with an apparatus as defined in claim 1.
• One advantage is that the lengths of tubing to be joined by welding can be properly aligned irrespective of the tubing diameters. Further advantages are that straight and leak- free joints of high strength can be obtained.
• Another aspect of the invention is to provide a method of welding thermoplastic tubing which allows aseptic welding independently of the tubing diameter over a range of diameters. This is achieved with a method as defined in the claims.
• a third aspect of the invention is to provide a welding apparatus that enables aseptic welding of thermoplastic tubing having a range of different diameters. This is achieved with an apparatus as defined in the claims.
• One advantage of this apparatus is that the tubing holders can
• a fourth aspect of the invention is to provide a welding apparatus that enables aseptic welding of thermoplastic tubing having a range of different diameters. This is achieved with an apparatus as defined in the claims.
• One advantage of this apparatus is that tubing of different diameters can be securely clamped without over-compression of the tubing.
• FIG. 1 shows an apparatus of the invention (top view), with the holders in the cutting position.
• Fig. 2 shows the apparatus of Fig. 1 with the holders almost in the welding position, with incomplete alignment of the tubing lengths to be welded.
• Fig. 3 shows the apparatus of Fig. 1 with the holders in the welding position, with the tubing lengths aligned by the aligning and abutment plates.
• Fig. 4 shows an apparatus of the invention (top view) with the holders a) in the cutting position, b) almost in the welding position and c) in the welding position with the tubing lengths aligned.
• Fig. 5 shows an alternative embodiment of the apparatus of the invention (top view) with the holders a) in the cutting position, b) almost in the welding position and c) in the welding position with the tubing lengths aligned.
• Fig. 6 shows an apparatus of the invention in a) top view, b) side view and c) front view with b) and c) also showing v blocks for accommodating different tube sizes and jaws for clamping the tubes.
• Fig. 7 shows the v blocks for accommodating different tube sizes (front and side view) with a) large diameter tubing and b) small diameter tubing.
• Fig. 8 shows the clamps with different clamping forces applied on a) large diameter tubing and b) small diameter tubing.
• the present invention discloses an apparatus 1;101 for aligning and supporting a first 2; 102 and a second 3; 103 length of thermoplastic tubing, preparatory to and during cutting and welding of the lengths of tubing.
• both lengths of tubing have the same diameter.
• the apparatus comprises the following components arranged on a base support 4: a) a first holder 5; 105 arranged to accommodate portions of the first 2; 102 and second 3; 103 lengths of tubing in a first 6; 106 and a second 7; 107 elongated holding space respectively, wherein the two holding spaces are essentially parallel to each other and separated from each other by a first distance 8; 108.
• the length axes of the two holding spaces can be arranged at an angle of less than 5 degrees, such as less than 2 degrees or less than 1 degree towards each other.
• a second holder 9; 109 arranged to accommodate (other) portions of the first 2; 102 and second 3;103 lengths of tubing in a third 10;110 and a fourth 11;111 elongated holding space respectively, wherein these holding spaces are essentially parallel to each other and to the holding spaces in the first holder (i.e.
• this second holder is movable, e.g. slidable, in a direction essentially perpendicular to the holding spaces of the first and second holders from a cutting position where the first holding space 6; 106 is aligned with the third holding space 10 and said second holding space 7; 107 is aligned with said fourth holding space 11;111 to a welding position where said first holding space 6;106 is aligned with said fourth holding space 11; 111.
• portions of the first length of tubing 2;102 can be accommodated in the first 6;106 and third 10;110 holding spaces, while portions of the second length of tubing 3; 103 can be accommodated in the second 7; 107 and fourth 11;111 holding spaces.
• a cut portion 19;119 of the first 2;102 length of tubing can be accommodated in the first holding space 6; 106 and aligned with a cut portion 20; 120 of the second 3; 103 length of tubing accommodated in the fourth holding space 11;111 ;
• the cutting means can be a hot cutting device such as e.g.
• the cutting means is suitably arranged to cut both lengths of tubing in an essentially transverse direction, such as at an angle of 85-95 degrees or 88-92 degrees to the length axis of each length of tubing.
• the wording "cutter” can be used interchangeably with “cutting means”.
• Aligning means arranged to abut the outside of a cut length of tubing 19; 119 accommodated in the first holding space 6; 106 and the outside of a cut length of tubing 20; 120 accommodated in the fourth holding space 11; 111 and to align these lengths of tubing with each other, typically in the transverse direction, when the second holder is in or is approaching the welding position. As the alignment is done directly by abutment of the outsides of the cut lengths of tubing, proper alignment is ensured irrespective of their diameter.
• the aligning means may comprise a first 14; 114 and a second 15; 115 aligning plate, both having substantially the same width 17; 117, each movable in a direction essentially perpendicular to (or at an angle of 85-95 degrees, such as 88-92 degrees to) the holding spaces of the first and second holders, and an abutment plate
• the disclosed abutment solution can be produced to a low cost, particularly compared to precision-controlled drives and precision machined parts for placing the holders at exactly determined positions.
• the aligning by abutment for flexible tubing works particularly well with tubes that have been pinched flat using clamps (see below) in that the side of a flattened tube is considerably more rigid than the non-flattened flexible tube and a higher abutment force can be applied to ensure alignment.
• the aligning plates may e.g. be slidable on a guideway against a spring load (The spring load will let the plates revert to home position after the operation).
• the face of the plate that abuts the tube can suitably be flat to ensure that the tube edge is always contacted.
• the aligning means may comprise a plate driven by a separate drive.
• One or both of the holders may be dividable, as illustrated in Fig. 5.
• the first holder 105 is dividable into two parts 105,104 when the second holder approaches the welding position.
• This arrangement has the advantage that access of the aligning plates 114, 115 and the abutment plate 116 to the cut tubing portions 119, 120 is facilitated. It is however also possible to use non- dividable holders as shown in Fig 1-4 and 6, particularly if the holders comprise recesses to accommodate the aligning and abutment plates into suitable positions.
• the apparatus further comprises a heater arranged to heat and weld together the ends of a cut length of tubing accommodated in the first holding space 6; 106 and a cut length of tubing accommodated in the fourth holding space 11; 111 and wherein said first and second holder are arranged to be urged together to accomplish a welded seal.
• a heated wafer is used as cutting means, the same heated wafer can also be the heater, but the heater can also be a separate device, e.g. another wafer, a laser, an infrared beam, a hot air source etc.
• An advantage of using a single heated wafer for both cutting and welding is that the cut ends can be kept in contact with the hot wafer during the entire operation, thus ensuring aseptic conditions.
• the urging together of the first and second holders can e.g. be achieved by arranging them to be slidable along one or two guides when in the welding position.
• the first and second alignment plates are arranged to slide against the abutment plate when said first and second holder are urged together. Sliding against the abutment plate is a way to ensure that the alignment is maintained when the holders are urged together.
• the abutment plate is spring loaded.
• the spring loading can e.g. be achieved by a helical spring and has the advantage that a suitable force is constantly applied to the aligning plates in order to ensure the alignment.
• the second holder is slidable along a guide 18. This ensures a smooth and precise motion between the cutting and welding positions and facilitates the alignment with the aligning means.
• the first, second, third and fourth holding spaces are arranged to accommodate tubing lengths having a range of outer diameters, such as a range of 4 - 25 mm, 4 - 10 mm, 10 - 25 mm, 5 - 20 mm or 7 - 15 mm. Tubing with different outer diameters in the 4- 25 mm range is commonly used in bioprocess settings and to allow a broad scope of use for the apparatus it is advantageous if it can handle either the entire range or significant parts of it.
• the holding spaces can be constructed as described below or they may e.g. be of large diameter and accommodate sets of smaller diameter cylindrical inserts which can be exchanged depending on the tubing diameter to be used.
• each of said holding spaces comprises two elongated spring loaded opposite v blocks 42 arranged to align the center axes of the tubing lengths along the center axes of the holding spaces.
• the v blocks can suitably be two elongated blocks, each having a v-shaped groove along the center axis of the holding space, with the v- shaped grooves of each block facing each other.
• the axial alignment is cooperative with the transverse alignment in that both are needed and that even a minimal misalignment in one direction further increases the need for precision alignment in the other direction.
• the v-block arrangement further ensures that the clamping force is applied centrally on the tubing. This is important, as non-central clamping can lead to transverse movement of the flattened tube.
• the alignment means are able to obtain alignment even of transversely dislocated tubing ends, the alignment operation is easier if the tubing ends are at the appropriate places. Non-central clamping can also lead to incomplete flattening of the tubes and consequential leakage of liquid.
• each holding space comprises two v blocks 42 arranged vertically above each other, with the v-shaped grooves 43 facing each other and with the blocks suspended by helical springs 44 from the top 45 and bottom 46 of a frame 47.
• the tubing can be accommodated between the v-shaped grooves and the helical springs allow movement of the blocks while applying a suitable force urging the blocks together to hold the tubing length in place and axially aligned without deformation of the tubing.
• Each block can suitably be suspended by a plurality of helical springs, such as two helical springs.
• each holder comprises a clamp 21;48;51 arranged to flatten a portion of a length of tubing accommodated in the holding spaces.
• the tubes need to be pinched in order to arrest the liquid inside the tube(s) while cutting and welding.
• the tubes will then be compressed to an essentially flat shape (e.g. such that opposite inside surfaces of the tubing are in direct contact with each other) and cut and welded in this shape.
• the clamps are released and the tubes with the weld spring back to cylindrical shape, if necessary assisted by lightly twisting the joint manually.
• each clamp 51 comprises two jaws 52 and between the jaws at least one compression spring 53 and at least one stopper 54.
• the at least one compression spring may e.g.
• the compression springs can e.g. be disc springs.
• the compression springs can be arranged to engage both jaws when the jaws are at a distance of up to 20 mm from each other, such as at a distance of up to 8, 10 or 15 mm from each other.
• the stoppers can e.g. be arranged to engage both jaws at a distance of 4-10 mm from each other, such as 4 - 7 mm or 5 - 10 mm from each other.
• Sufficient compression is needed to prevent any leakage of liquid during cutting and welding, but over-compression can damage the tubing material and also cause undesirable deformation during welding. It may e.g. lead to closed welds that do not spring back upon release of the clamps.
• the present invention discloses a method of cutting and welding a first 2; 102 and a second 3; 103 length of thermoplastic tubing, comprising the steps of:
• the method comprises, between steps b) and c), a step b') of clamping both the first and second length of tubing to an essentially flat shape (e.g. such that opposite inside surfaces of the tubing are in direct contact with each other). As discussed above, this facilitates welding when liquid is present in at least one of the lengths of tubing.
• the tubing used can suitably be flexible, such as tubing manufactured from e.g. thermoplastic elastomers or plasticized PVC.
• the method can further, after step f) comprise a step f ) of releasing the clamping.
• the present invention discloses an apparatus 1;101 for aligning and supporting a first 2; 102 and a second 3; 103 length of thermoplastic tubing, preparatory to and during cutting and welding of said lengths of tubing, said apparatus comprising the following components arranged on a base support 4:
• a second holder 9; 109 arranged to accommodate portions of said first and second lengths of tubing in a third 10;110 and a fourth 11;111 elongated holding space respectively, wherein said holding spaces are essentially parallel to each other and to the holding spaces in the first holder and separated from each other by a second distance 12; 112 substantially the same as the first distance 8; 108, and wherein said second holder is slidable in a direction essentially
• each of said first, second, third and fourth holding spaces comprises two elongated spring loaded opposite v blocks 42, as defined above, arranged to align the center axes of the tubing lengths along the center axes of the holding spaces.
• each holding space comprises two v blocks 42 arranged vertically above each other, with the v-shaped grooves 43 facing each other and with the blocks suspended by helical springs 44 from the top 45 and bottom 46 of a frame 47.
• the present invention discloses an apparatus 1;101 for aligning and supporting a first 2; 102 and a second 3; 103 length of thermoplastic tubing, preparatory to and during cutting and welding of said lengths of tubing, said apparatus comprising the following components arranged on a base support 4:
• a second holder 9; 109 arranged to accommodate portions of said first and second lengths of tubing in a third 10;110 and a fourth 11;111 elongated holding space respectively, wherein said holding spaces are essentially parallel to each other and to the holding spaces in the first holder and separated from each other by a second distance 12; 112 substantially the same as the first distance 8; 108, and wherein said second holder is slidable in a direction essentially
• each clamp 51 in each holder, a clamp 51 arranged to flatten a portion of a length of tubing accommodated in the holding spaces, wherein each clamp 51 comprises two jaws 52 and between the jaws at least one compression spring 53 and at least one stopper 54.

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• Heart & Thoracic Surgery (AREA)
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• 2014
  • 2014-10-22 JP JP2016524460A patent/JP6540694B2/ja active Active
  • 2014-10-22 US US15/030,560 patent/US10183447B2/en active Active
  • 2014-10-22 IN IN3155DE2013 patent/IN2013DE03155A/en unknown
  • 2014-10-22 EP EP14855384.5A patent/EP3060292B1/en active Active
  • 2014-10-22 WO PCT/SE2014/051240 patent/WO2015060774A1/en active Application Filing
  • 2014-10-22 CN CN201480058189.8A patent/CN105636640B/zh active Active

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